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Acute Myocarditis Registry With Prognostic, Histologic, Immunologic, Biological, Imaging and Clinical Assessment

Acute Myocarditis Registry With Prognostic, Histologic, Immunologic, Biological, Imaging and Clinical Assessment

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04844151
Acronym
AMPHIBIA
Enrollment
1400
Registered
2021-04-14
Start date
2022-01-23
Completion date
2041-05-01
Last updated
2025-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocarditis

Keywords

Cardiomyopathies, Inflammatory heart disease, Magnetic resonance imaging, Viral

Brief summary

The AMPHIBIA study is an observational ambispective and prospective cohort that aim to describe the histologic, immunologic, biological, imaging, genetic and clinical characteristics of the patients hospitalized for an acute myocarditis and to evaluate their association with prognosis.

Detailed description

Acute myocarditis is an inflammatory disease of the heart muscle. Its clinical presentation and its etiologies are multiple and make it a complex disease to treat. Its course also varies, ranging from complete clinical recovery to recurrence of ventricular arrhythmia or progression to chronic dilated heart disease, while being difficult to predict. The long-term prognosis is poorly understood. Consecutive patients hospitalized in a tertiary university referral center cohort from 2006 to 2041 for an acute myocarditis will be ambispectively or prospectively analyzed. This project will establish a registry including up to 400 patients in the ambispective analysis cohort from 2006 to 2021 and 1000 patients in the prospective analysis cohort during a 20 years inclusion period. The aim of the study is to describe the characteristics of patients hospitalized for an acute myocarditis and to evaluate their association wih the long term (until 20 years) prognosis. Features of interest will include : * Clinical * Biological * Etiological * Echocardiographic * Cardiac magnetic resonance imaging * Genetics (for the prospective cohort) * Anatomopathological The collection of clinical, biological and radiological data will represent an unique source allowing research teams in the coming years to access the data necessary to answer various specific questions (pathophysiological, diagnostic, prognostic) relevant to the state of knowledge on this pathology.

Interventions

None listed

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Acute myocarditis confirmed by cardiac magnetic resonance according to Lake Louise modified criteria or by endomyocardial biopsy according to histologic, immunologic and immunohistochemic criteria. * affiliation to the French Health Care System Sécurité sociale

Exclusion criteria

* Severe valvulopathy * Complex congenital cardiopathy * Previous heart transplant * Known significative coronary disease

Design outcomes

Primary

MeasureTime frameDescription
Major cardiac eventsup to 1 yearsDefined as a composite of : * All cause death * Resuscitated cardiac arrest * Heart transplant * Longterm mechanical circulatory support * Ventricular arrhythmia after discharge * Hospitalization for heart failure * Hospitalization for myocarditis recurrence

Secondary

MeasureTime frameDescription
All cause deathup to 20 years
Cardiovascular deathup to 20 years
Heart transplantup to 20 yearsNumber of patients with heart transplant
Sustained ventricular arrhythmia after dischargeup to 20 yearsNumber of patients with sustained ventricular arrhythmia after discharge
Resuscitated cardiac arrestup to 20 yearsNumber of patients with resuscitated cardiac arrest
Longterm mechanical circulatory supportup to 20 yearsNumber of patients implanted with a longterm mechanical circulatory support
Hospitalization for myocarditis recurrenceup to 20 yearsNumber of patients hospitalized for myocarditis recurrence
Major cardiac eventsup to 20 yearsDefined as a composite of : * All cause death * Resuscitated cardiac arrest * Heart transplant * Longterm mechanical circulatory support * Ventricular arrhythmia after discharge * Hospitalization for heart failure * Hospitalization for myocarditis recurrence
Pericardial drainageup to 20 yearsNumber of patients with a surgery of pericardial drainage
Supra ventricular arrythmiaup to 20 yearsNumber of patients with a new onset of supra ventricular arrhythmia
High grade atrioventricular blockup to 20 yearsNumber of patients with a new high grade atrioventricular block
Pericarditisup to 20 yearsNumber of patients with pericarditis diagnosed by the patient referring physician's
Left ventricular systolic function under 50%up to 20 yearsEvaluated by transthoracic echocardiography
Therapeutics during hospital stayFrom the day of admission up to 90 daysType and duration of therapeutics received during the initial hospital stay
Hospitalization for heart failureup to 20 yearsNumber of patients with hospitalization for heart failure

Countries

France

Contacts

Primary ContactMathieu Kerneis, MD
mathieu.kerneis@aphp.fr+33142163001

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026